Objectives: The primary objective of the APPEAL study was to assess overall subject satisfaction of glabellar lines (GL) treatment after 3 injection cycles of abobotulinumtoxinA (aboBoNT-A). Secondary objectives included a description of injection practices, with a focus on interval times between injection cycles.
Introduction: Hyperfunctional lines, such as GL, are caused by prolonged contraction of facial muscles and can lead to wrinkles, negative facial expressions or an aged appearance. Severe GL can have a negative psychological impact on a patient. Botulinum neurotoxin type A injections can temporarily weaken hyperfunctional muscles, and repeated treatments are required to maintain therapeutic advantage. The APPEAL study assessed subject and physician satisfaction of long-term GL treatment with aboBoNT-A in a real-life setting. Here we present injection interval data between Cycles 1 and 2, and 2 and 3.
Materials / method: The APPEAL study (NCT02353897) was a multicentre, non-interventional, prospective, longitudinal study in subjects with moderate-to-severe GL, who received ≥3 cycles of aboBoNT-A injections. Subjects completed a subject satisfaction questionnaire 3 weeks (±7 days) after each cycle. Shortest injection interval was 12 weeks, according to the local summary of product characteristics (SmPC) and maximum interval time was 6 months, determined at the investigators discretion. Descriptive statistics were performed for injection interval times overall, between Cycles 1 and 2, and between Cycles 2 and 3.
Results: After Cycle 3, 99% of subjects (n=134/135) were ‘very satisfied’ (74%) or ‘satisfied’ (25%) with GL correction. Median drug exposure was 309.5 days (range, 1–426 days). 137 (91%) subjects received 3 injection cycles, 3 (2%) received 2 cycles and 10 (7%) received 1 cycle. Overall interval data were available for 140 subjects. Median overall interval time (days [range]) was 10.6 months (320 [228–426] days). Median injection interval time (days [range]) was 5.0 months (152 [85–267] days) between Cycles 1 and 2 (n=140), and 5.3 months (161 [104–211] days) between Cycles 2 and 3 (n=137).
Conclusion: In the APPEAL study, there was a high level of satisfaction following 3 injection cycles of aboBoNT-A. Furthermore, physicians’ injection practices and the interval time between injection cycles aligned with the recommendations of local SmPCs, with a median retreatment interval of 5 months.
Declaraciones
¿Ha recibido algún tipo de financiamiento para realizar su investigación sobre esta temática?
Si
Por favor especifique las entidades (individuo, empresa, sociedad): Ipsen
¿Ha recibido algún pago, honorario u otra compensación por su trabajo acerca de esta investigación?
No
¿Tiene vínculos financieros con alguna entidad que podría llegar a competir estrechamente con los medicamentos, materiales o instrumentos tratados en su investigación?
No
¿Posee o ha solicitado una patente relacionada a los materiales, productos o instrumentos utilizados en su investigación?
No
Este trabajo es presentado gracias al apoyo de: Ipsen